Health TrialsbyHealthPanel

PSTC100 Study in Healthy Adult Subjects

ConditionHealthy Adult Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorProspect Therapeutics (Nanjing) Limited

About this trial

This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1.Fully understand the purpose and process of this study, voluntarily participate, and sign an informed consent form;

2.At the time of screening, applicants must be between 18 and 55 years old (inclusive), and there are no gender restrictions.

3.Body mass index (BMI) is between 18.0 and 32.0 kg/m² (inclusive).

4.Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg.

Disqualifiers

1.Pregnant women (or those with a positive pregnancy test), or breastfeeding women;

2.During the screening and baseline period, the pulse rate ≤ 45 beats/minute or > 100 beats/minute;

3.During the screening and baseline period, systolic blood pressure <90 mmHg or ≥140 mmHg, or diastolic blood pressure <50 mmHg or ≥90 mmHg;

4.Those who have special dietary requirements and cannot accept the standardized meals provided by the research center;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PSTC100 tablets

    Drug

    PSTC100 tablets

  • PSTC100 tablets

    Drug

    dose 7 once daily, dose 8 once daily, dose 9 once daily

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: A SAD study includes 6 dose cohorts: Cohorts 1-6Experimental treatment 1 intervention
Group B: A MAD study with randomized, double-blind, placebo-controlledExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to Peak Concentration (Tmax),

PK characteristics after single dose

Time frame
Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
2

Peak Concentration (Cmax),

PK characteristics after single dose

Time frame
Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
3

Area Under the Concentration - Time Curve (AUC0-24h, AUC0-t, AUC0-∞, etc.)

PK characteristics after single dose

Time frame
Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
4

Apparent volume of distribution (Vd/F)

PK characteristics after single dose

Time frame
Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

Secondary outcomes

1

Glucose metabolism indicators

Routine glucose metabolism indicators include: FPG, FINS, HOMA-IR, and HOMA-β. Blood samples will be collected to test routine glucose metabolism indicators. The absolute change and percentage change of endpoints relative to baseline will be calculated, and endpoint-time curves will be plotted for each dose cohort.

Time frame
Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.
2

Lipid metabolism indicators

Routine lipid metabolism indicators include: LDL-C, HDL-C, CHO, TG, etc. Blood samples will be collected to test routine lipid metabolism indicators. The absolute change and percentage change of endpoints relative to baseline will be calculated, and endpoint-time curves will be plotted for each dose cohort.

Time frame
Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Nucleus Network Sydney Pty LtdRecruiting2065, Saint Leonards, New South WalesAustraliaAustralia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prospect Therapeutics (Nanjing) Limited

Lead sponsor

Source ClinicalTrials.gov
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